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Revise WHO biosimilar guidelines urgently

Third World Network asks African civil society organisation to support its letter to the Chair WHO Expert Committee on Biologic Standardisation (EBCS) to revise the WHO biosimilar guidelines. The South African NCDs Alliance has signed.
The content below is from TWN.


In 2014, WHA adopted the resolution on access to Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy” (WHA 67.21).

It requests the Director-General: “to convene
t). the WHO Expert Committee on Biological Standardization to update the 2009 guidelines, taking into account the technological advances for the characterization of biotherapeutic products and considering national regulatory needs and capacities and to report on the update to the Executive Board
”. However, till date, the Secretariat has not updated the SBP Guideline.

WHO states that after the adoption of the  WHA resolution   “In April 2015, an informal consultation was organized during which participants from NRAs of both developing and developed countries, as well as from industry, recognized and agreed that the evaluation principles described in the Guidelines were still valid, valuable and applicable in facilitating the harmonization of SBP regulatory requirements globally. It was therefore concluded that there was no need to revise the main body of the existing Guidelines“.

This is a problematic approach and legally wrong. The resolution is clear and it asked the DG to convene the meeting of  WHO Expert Committee on Biological Standardization to update the Guideline and not to convene the meeting of  Expert Committee on Biological Standardization to decide whether to update or not. Further, the decision of  Member states cannot be overturned by the informal meeting of  National Regulatory Meetings. Further WHO has not published any verbatim records or minutes of the 2015 informal meeting. 

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